COVID-19 Neutralising IgG Serological Test

Self-test for the detection of SARS-CoV-2 antibodies after vaccination

  • WHAT IS THE
    COVID-19 NEUTRALISING IgG SEROLOGICAL TEST FOR?

    COVID-19 Neutralising IgG Serological Test is a rapid device which verifies the presence of COVID-19 neutralising IgG antibodies in human blood samples produced after the end of the vaccination cycle.

  • NEUTRALISING IgG ANTIBODIES AND SPIKE PROTEIN

    One of the most important proteins involved in the virus infection process is the Spike protein, which covers the whole virus' surface, forming characteristic protuberances that make it look like a crown - hence the name “Coronavirus”. This is divided in two portions: the first one contains a region known as RBD (Receptor Binding Domain), that allows the virus to bind to the host cell by adhering to specific receptors and to penetrate in the organism, thus inhibiting the infection process and the associated COVID-19 disease.

    For this reason, the Spike protein has been used as an immunological target in the development of the vaccines against SARS-CoV-2 and the IgG anti-SARS-CoV-2 Spike/RBD antibodies are defined as neutralising.

  • WHO DOES USE
    THE COVID-19 NEUTRALISING IgG SEROLOGICAL TEST?

    COVID-19 Neutralising IgG Serological Test is useful for everyone who wants to verify the post vaccine immune response. It is suggested to wait at least 14 days after the end of the vaccination cycle before performing the test.

    Seroconversion evaluations are still ongoing on different vaccines on the market, please refer to the table below for an update of the obtained results.

    Vaccine Type Amount of sample tested Seroconversion Rate When should I use the test? Location
    Pfizer BioNTech Cominarty 234 98.3%
    (95% C.I.: 95.6-99.3%)
    Starting from 14 days after the end of the vaccination cycle Cancer National Institute, Oncology Department and Haematology Department (Milan Italy); Interuniversity Center for Research on Influenza and other Transmissible infections (CIRI-IT, Genova, Italy); Istituto Mario Negri (Bergamo, Italy)
    Oxford-AstraZeneca 68 98.5%
    (95% CI: 92.1-99.7%)
    Starting from 14 days after the end of the vaccination cycle PRIMA Lab SA in collaboration with the Biological Laboratory of the Italian Fire Brigade (Laboratorio Biologico dei Vigili del Fuoco, Milan, Italy)
    Moderna mRNA-1273 21 95.2%
    (95% CI: 77.3-99.2%)
    Starting from 14 days after the end of the vaccination cycle PRIMA Lab SA (Balerna, Switzerland)

  • HOW DOES
    THE COVID-19 NEUTRALISING IgG SEROLOGICAL TEST WORK?

    The test is based on an immunochromatographic reaction starting from a blood sample: if IgG anti-SARS-CoV-2 Spike/RBD antibodies are present in the sample, a red line will appear in the test region in just 10 minutes.

  • WHAT DOES IT CONTAIN?

    • instructions for use
    • 2 sterile lancets for self-puncture and blood sampling
    • 1 antiseptic cleaning gauze
    • 1 dropper vial containing the diluent for the Test
    • 1 plastic pipette for blood sampling
    • 1 sealed aluminum bag containing:
    • 1 Test device 1 desiccant sachet

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